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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020405
Company: ADVANZ PHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LANOXIN DIGOXIN 0.0625MG TABLET;ORAL Prescription AB Yes No
LANOXIN DIGOXIN 0.125MG TABLET;ORAL Prescription AB Yes No
LANOXIN DIGOXIN 0.1875MG TABLET;ORAL Discontinued None Yes No
LANOXIN DIGOXIN 0.25MG TABLET;ORAL Prescription AB Yes Yes
LANOXIN DIGOXIN 0.375MG TABLET;ORAL Discontinued None No No
LANOXIN DIGOXIN 0.5MG TABLET;ORAL Discontinued None No No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
04/29/2024 SUPPL-17 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020405Orig1s017lbl.pdf
02/22/2019 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020405s015lbl.pdf
08/24/2018 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020405s14lbl.pdf
12/01/2016 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020405s013lbl.pdf
07/28/2015 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020405s011lbl.pdf
10/17/2013 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020405s007lbl.pdf
08/13/2012 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020405s005lbl.pdf
11/14/2011 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020405s006lbl.pdf
02/05/2010 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020405s004lbl.pdf
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